NervGen Pharma Corp. Common stock Status update
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Good morning, and welcome to the NervGen Research and Development Day. My name is Daniel, and I will be your moderator today. All participants are in listen-only mode. Following the presentations from both NervGen management and the guest presenters, we will hold a question and answer session. Analysts who have been provided with a separate link to participate in the Q&A will be able to unmute and ask their questions live when the session begins. Please note that today's event is being recorded. A replay will be available on the Events and Presentations section of NervGen's website. Before we begin, please note that today's presentation contains forward-looking statements within the meaning of applicable Canadian and U.S. securities laws. These include statements about NVG-291, the CONNECT SCI study, the design and timing of the phase III RESTORE study, regulatory interactions, and the company's financial resources and operating runway.
These statements are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially. Please refer to the cautionary note on this slide and to the risk factors in NervGen's most recent annual information form, Form 40-F, and other filings available on SEDAR+ and EDGAR. I will now turn the call over to Dr. Adam Rogers, Chairman and Chief Executive Officer of NervGen.
Dr. Rogers? Thank you very much.
I am Adam Rogers, CEO of NervGen, and I want to thank everyone for joining us here today for our inaugural Research and Development Day. The spinal cord injury community remains one of the largest underserved populations, with over 300,000 affected individuals in the United States alone. Yet we have no FDA-approved therapeutic options available to improve function and independence. This is our mission at NervGen, is to bring a drug to market that is going to improve the lives of individuals with spinal cord injury. As we initiate our pivotal phase III RESTORE study in individuals living with chronic cervical motor incomplete spinal cord injury, we are delighted to continue to shed light on the importance of NVG-291, NervGen's 35 amino acid peptide that is administered very conveniently at home as a once-daily subcutaneous injection. Joining me today is Dr. Marc DePaul.
This is from our management team. He is a Senior Director of Research. Marc came out of the lab of Dr. Jerry Silver and has been with the company since 2017. Christine McSherry, who is NervGen's Senior Vice President of Patient Advocacy and Clinical Affairs. If I could have the next slide, please. I am also delighted to have key opinion leaders here to provide their expertise. Today, you are going to hear from guest speakers that are going to be scattered throughout the presentation. Dr. Ben Abramoff is the Director of the Spinal Cord Injury Program and is the Associate Professor of Rehabilitation Medicine at the University of Pennsylvania. Dr. Sukhvinder Kalsi-Ryan is from the University Health Network in Toronto.
Dr. Kalsi-Ryan is the lead developer of the GRASP assessment, which measures upper limb and hand function in individuals with cervicomedullary spinal cord injury, or as we will refer to as SCI throughout this presentation. GRASP quantitative prehension is NervGen's primary endpoint in our phase III RESTORE study. We will hear from Dr. Kalsi-Ryan regarding the development, validation, sensitivity, and reliability of the GRASP test. We also have Dr. Philippa Warren. She is the Sir Henry Dale Fellow from the School of Neuroscience at King's College London. Dr. Warren will discuss the scientific rationale for targeting chondroitin sulfate proteoglycans, also known as CSPGs, and the preclinical use of NVG-291. Just a quick note, in her slide, she may use the term ISP, which stands for intracellular sigma peptide, which is the laboratory name of NVG-291. They are interchangeable. Finally, we have Barry Munro, who is the Chief Development Officer of the Canadian Spinal Research Organization and also Director of the North American Spinal Cord Injury Consortium, who will discuss advocacy in the spinal cord injury community.
Next slide, please. Today's agenda will focus on the continued and significant unmet need of spinal cord injury, the scientific rationale and nonclinical foundation of NVG-291, and what gives us at NervGen the confidence for continued translation into the clinic. NervGen's clinical data generated in our phase I and phase I-B/II-A programs, the study design, rationale, and oversight plan for our phase III RESTORE study. We will conclude with the community and real-world advocacy perspectives. Next slide, please. NVG-291 has the potential to revolutionize recovery after spinal cord injury, positioning NervGen as a compelling and unique late-stage clinical development company.
Not only are we addressing a significant unmet medical need, with currently no approved drugs to restore lost function, improve independence, or quality of life for those with spinal cord injuries, but we are redefining what it potentially means to treat CNS damage in its entirety by regenerating neurons. This ability to regenerate neurons is a concept that was thought for many generations in medicine to be impossible. Confidence in NVG-291 is supported by our I-B/II-A CONNECT study, a placebo-controlled study that demonstrated efficacy across functional, electrophysiological, and participant-reported measures. All of these that we will touch on later today in the presentation. This observed efficacy that we saw in the CONNECT study resulted in alignment with the FDA on our pivotal Phase III RESTORE study, which we have officially begun screening patients following initial site activation this past week.
The use of NVG-291 has the potential to extend well beyond spinal cord injury. Think of it as a pipeline and a product. Dr. Marc DePaul, our Senior Director of Research, will highlight the existing preclinical data across additional neurologic conditions and diseases that support our confidence in being able to target the upregulation of the inhibitory chondroitin sulfate proteoglycans, or CSPGs, following CNS disruption or trauma to the central nervous system. There is a palpable excitement here at NervGen, as well as for the whole spinal cord injury community, and it is one that we have worked tirelessly over the last 18 months to arrive at. If you could turn to the next slide, please. During this time, over the past 18 months, we at NervGen have achieved key milestones that have successfully positioned our company to execute upon the RESTORE study.
We've demonstrated proof of concept of efficacy from our phase I-B/II CONNECT study. We've achieved alignment with the FDA on the phase III RESTORE study design. On a corporate level, NervGen successfully listed in January 2026 onto NASDAQ under the ticker NGEN, increasing the potential for broad investor awareness and to support the potential of continued financial growth. Next slide, please. One of my missions since becoming CEO last July is to build a senior leadership team that brings with them the clinical, regulatory, and financial expertise to successfully execute upon a late-stage clinical development study. I put together a team that understands what it takes to win in areas of significant unmet medical need and bring NVG-291 to market to improve the lives of those living with spinal cord injury.
NervGen will continue to selectively grow as we advance through the RESTORE study and prepare to commercialize NVG-291 as potentially the first approved pharmacologic treatment for the spinal cord injury community. Next slide, please. Before I turn the presentation over to Dr. DePaul and Dr. Philippa Warren to discuss the non-clinical and scientific foundation of NVG-291, what I want to do is take a few minutes over the next handful of slides to highlight the significant unmet need of spinal cord injury that we're addressing. Next slide. Spinal cord injury has a profound impact both globally and within the U.S. Worldwide, there are over 15 million individuals living with spinal cord injury. In the United States, when you focus on those individuals just with traumatic injuries, there are over 300,000 individuals with an annual incidence of 18,000 new cases of traumatic spinal cord injury.
In RESTORE, we will be enrolling individuals similar to the CONNECT study with traumatic cervical motor incomplete spinal cord injury C7 or higher, which, as you can see towards the bottom right-hand side of the slide, represents a population of about 50% of the prevalent population here, or roughly 150,000 individuals in the U.S. This is a very large population. This is an enormous potential market opportunity for NVG-291, and it further gives us confidence at NervGen in our ability to successfully enroll, RESTORE, and commercialize NVG-291. Next slide. It cannot be understated the real-world impact that a spinal cord injury has on an individual, their family, and society at large. Later in today's presentation, towards the end, Christine McSherry and Barry Munro are going to contextualize for you all the continued unmet need and the work that's being done.
Statistically speaking, in the U.S., spinal cord injuries most commonly occur in middle age. The average age is roughly 44 years. As you can see on the slide right, more men are affected than women. Financially, spinal cord injury imparts a dramatic economic burden, both on society as a whole, there's roughly a $60 billion hit to the U.S. healthcare system, and to an individual, there's up to $8 million in lifetime costs for that person. So any therapy that we can bring to market that has the potential to decrease that lifetime cost and economic burden to the system and allow for the potential of an individual to reenter the workforce or reduce the need for a caregiver, has the potential for a significant economic impact, and we firmly believe that NVG-291 has that potential. Next slide. When we focus on traumatic spinal cord injury, which the phase III RESTORE is enrolling, the leading recovery priority for these individuals is improvement in hand function.
This is going to resonate throughout our entire presentation today as we discuss the GRASP study, but you will see the number 77% that is on the right-hand side of the slide repeated many times throughout. Dr. Abramoff and Dr. Sukhvinder Kalsi-Ryan will discuss this importance of hand function in more detail, but as you can see, within the cervicomedullary spinal cord community, roughly 77% of all individuals who have a cervical spinal cord injury indicate that use of their hands would meaningfully improve quality of life.
That probably runs opposite of what most people would think, because as an outsider, most of us would think that just the ability to walk again, but it is really the use of your hand, which gives individuals the ability to use their iPhone, use their computer, the ability to cook or open a bottle of water up. It gives them independence. It is this community feedback that we have received, along with the alignment with the FDA, as to why NervGen structured the RESTORE Study, really to focus on fine hand motor use via GRASP quantitative prehension as our primary endpoint for the study. Next slide. I am going to turn it over now to Dr. Marc DePaul and Dr. Philippa Warren to review chondroitin sulfate proteoglycans and NVG-291. Marc and Philippa, I am going to turn it over to you.
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